Effects of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

This study has been completed.
Sponsor:
Information provided by:
Chiba University
ClinicalTrials.gov Identifier:
NCT00668876
First received: April 28, 2008
Last updated: December 2, 2008
Last verified: October 2008

April 28, 2008
December 2, 2008
May 2006
January 2008   (final data collection date for primary outcome measure)
surgical site infection after surgery [ Time Frame: 30days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00668876 on ClinicalTrials.gov Archive Site
plasma IL-6, CRP, Th1/Th2 balance, Th17 status [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy
Effects of Immunonutrition on Surgical Site Infection and Th1/Th2/Th17 Differentiation in Patients Undergoing Pancreaticoduodenectomy

The purpose of this study is to determine whether immunonutrition is effective on surgical site infection and Th1/Th2/Th17 differentiation in patients undergoing pancreaticoduodenectomy

Perioperative immunonutrition is reported to improve the incidence of postoperative infectious complication in patients with gastrointestinal surgery. It has also been recognized that Th1/Th2 balance shifts toward Th2 by surgical stress. On the other hand, the change of Th17 status after surgery has not been established. Furthermore, The change of Th1/Th2 balance and Th17 status with immunonutrition on pancreaticoduodenectomy have not been reported yet.

Objective of this study is to investigate the effects of perioperative immunonutrition on incidence of postoperative infectious complication, Th1/Th2 balance and Th17 status after pancreaticoduodenectomy.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Pancreaticoduodenectomy
  • Dietary Supplement: Oral IMPACT
    oral supplementation for 5 days(1 L/d )before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA
    Other Name: oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan
  • Dietary Supplement: Oral IMPACT
    postoperative enteral infusion of the formula with arginine, omega-3 fatty acids, and RNA
    Other Name: Oral IMPACT
  • Dietary Supplement: Parenteral nutrition
    Parenteral nutrition
  • Active Comparator: 1
    Group A: perioperative immunonutrition
    Intervention: Dietary Supplement: Oral IMPACT
  • Active Comparator: 2
    Group B: postoperative immunonutrition
    Intervention: Dietary Supplement: Oral IMPACT
  • Active Comparator: 3
    Group C: control
    Intervention: Dietary Supplement: Parenteral nutrition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients underwent pancreaticoduodenectomy

Exclusion Criteria:

  • age younger than 18 years or older than 75 years
  • preoperative chemotherapy or radiation
  • ongoing infection
  • diabetes mellitus
  • gastrointestinal obstruction
  • respiratory dysfunction
  • cardiac dysfunction
  • hepatic dysfunction
  • renal failure
  • history of recent immunosuppressive or immunological diseases
  • preoperative evidence of widespread metastatic disease
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00668876
furukawa2008
No
Chiba University
Chiba University
Not Provided
Principal Investigator: Daisuke Suzuki Chiba University
Chiba University
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP